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Operational and Institutional Recommendations and Requirements for TAVR: A Review of Expert Consensus and the Impact on Health Care Policy

Neuburger, Peter J; Luria, Brent J; Rong, Lisa Q; Sin, Danielle N; Patel, Prakash A; Williams, Mathew R
When transcatheter aortic valve replacement (TAVR) was first approved for use in the United States in 2012, multiple leading surgical and cardiology societies were tasked with creating recommendations and requirements for operators and institutions starting and maintaining TAVR programs. Creation of this consensus document was challenging due to limited experience with this new technology, and a lack of robust centralized data that could be used to validate outcome measures and create benchmarks for self-assessment and improvement. Despite these limitations, this document provided government agencies a framework for regulation that ultimately determined requirements for Medicare payment for TAVR and therefore greatly determined how and where care was delivered for patients with aortic stenosis. After the proliferation of TAVR institutions throughout the US and with data from more than 100,000 cases in the STS/ACC Transcatheter Valve Therapies TM Registry, leaders of the same societies reconvened in 2018 to update their consensus document. The new recommendations include suggested personnel, facilities, training, and assessment of outcomes and competencies required to run a safe and efficient TAVR program. This article seeks to detail the changes from the original consensus document with a particular focus on issues relevant to cardiac anesthesiologists as well as important healthcare policy ramifications for patients and providers in the United States.
PMID: 30852090
ISSN: 1532-8422
CID: 3732852

Can complex mitral valve repair be performed with robotics? An institution's experience utilizing a dedicated team approach in 500 patients

Loulmet, Didier F; Ranganath, Neel K; Neuburger, Peter J; Nampiaparampil, Robert G; Galloway, Aubrey C; Grossi, Eugene A
OBJECTIVES/OBJECTIVE:The full potential of robotics has not been achieved in terms of addressing the most challenging mitral valve (MV) cases. We outline our technique and report our early results with totally endoscopic robotic MV repair in a wide range of pathologies. METHODS:From May 2011 to August 2017, a dedicated team attempted totally endoscopic robotic MV repair in 500 MV regurgitation patients. Repair complexity was scored in 3 categories. We analysed our sequential case experience by quartiles. RESULTS:Patient mean age was 60.8 years (range 18-88). Aetiologies included: degenerative 382 (76.4%), functional 37 (7.4%), inflammatory 22 (4.4%) and others 59 (11.8%). Mitral annular calcification was present in 64 (12.8%) cases. Simple MV repair (annuloplasty alone or with 1 leaflet segment repair) was performed in 240 (48%) patients, complex (repair involving more than 1 segment on the same leaflet) in 140 (28%) patients and most complex (bileaflet repair or mitral annular calcification excision with atrioventricular groove repair) in 120 (24%) patients. Concomitant procedures included: left appendage closure (94.8%), patent foramen ovale/atrial septal defect (PFO/ASD) closure (19.6%), cryoablation (19.4%), tricuspid repair (6.2%) or hybrid percutaneous coronary revascularization (7.8%). The overall repair rate was 99.4%, with 0.6% early mortality and 1.2% stroke rate (0.2% permanent neurological deficit). Case complexity increased with our experience. Despite an increase in aortic occlusion and perfusion times (median 86.5 and 125 min) and a slight decrease in operating room extubation rate (overall 64%), length of hospital stay (median 4 days) and 30-day readmission rate (overall 3.6%) were not affected by the progressive inclusion of more complex cases. CONCLUSIONS:Totally endoscopic robotic MV repair performed by a dedicated team allows one to address the entire spectrum of pathological complexity and provides consistent results.
PMID: 30753381
ISSN: 1873-734x
CID: 3656212

Systematic Transfemoral Transarterial Transcatheter Aortic Valve Replacement in Hostile Vascular Access

Staniloae, C S; Jilaihawi, H; Amoroso, N S; Ibrahim, H; Hisamoto, K; Sin, D N; Lee, H; Du, R; Zhao, Z -G; Neuburger, P J; Williams, M R
Background: Traditionally, hostile peripheral access patients undergo TAVR via alternative access. We describe the "transfemoral-first" (TF-1) approach in patients with hostile peripheral access. Method(s): Clinical and procedural data were obtained for all TAVR cases performed from August 2016 to July 2017. Computed tomography was used to assess iliofemoral arteries. Patients were divided into three femoral access groups: routine, hostile, and prohibitive. We attempted TF access in all patients with routine and hostile access. Hostile access was defined as: (1) arterial segments with diameter <5.0 mm; or (2) <5.5 mm with severe calcification (270-360degree arc of calcification) or severe tortuosity; or (3) severe tortuosity along with severe calcification. Outcomes of the hostile access group patients who underwent TF-1 are described. The primary endpoint was successful completion of the procedure without major complications by the intended route. The secondary endpoints were procedural complications as defined by the VARC-2 criteria. Result(s): Of 377 consecutive patients, 99.5% underwent TF-1 TAVR; two patients (0.4%) had prohibitive access. Twenty-eight (7.4%) patients had hostile access with access side mean minimal lumen diameter of 4.7 mm (range 3.8-5.4 mm). Twenty-six (92.8%) were successfully treated with TF-1 strategy. Twelve (42.8%) of the 26 patients underwent preparatory endovascular treatment prior to TAVR during the same operating room visit. There was 1 (3.5%) major or life-threatening bleeding complication and 2 (7.1%) major vascular complications. There were no deaths or strokes. Conclusion(s): Using the safe and effective endovascular approach, TF-1 TAVR is feasible for all-comers-including those with hostile access-with low complication rate. Larger studies are warranted to validate this approach.
EMBASE:625851743
ISSN: 2474-8714
CID: 3596002

Ongoing Obstacles for Universal Use of Sedation for Transfemoral Transcatheter Aortic Valve Replacement [Editorial]

Patel, Prakash A; Neuburger, Peter J
PMID: 30217588
ISSN: 1532-8422
CID: 3278472

Intraoperative Measurement of the Tricuspid Annulus: To 3D or not to 3D? [Editorial]

Chacon, M Megan; Neuburger, Peter J
PMID: 30122609
ISSN: 1532-8422
CID: 3246282

Perioperative Care of the Obese Cardiac Surgical Patient

Chacon, M Megan; Cheruku, Sreekanth R; Neuburger, Peter J; Lester, Laeben; Shillcutt, Sasha K
Morbid obesity is associated with impairment of cardiovascular, pulmonary, gastrointestinal, and renal physiology with significant perioperative consequences and has been linked with higher morbidity and mortality after cardiac surgery. Cardiac surgery patients have a higher incidence of difficult airway and difficult laryngoscopy than general surgery patients do, and obesity is associated with difficult mask ventilation and direct laryngoscopy. Positioning injuries occur more frequently because obese patients are at greater risk of pressure injury, such as rhabdomyolysis and compartment syndrome. Despite the association between obesity and several chronic disease states, the effects of obesity on perioperative outcomes are conflicting. Studies examining outcomes of overweight and obese patients in cardiac surgery have reported varying results. An "obesity paradox" has been described, in which the mortality for overweight and obese patients is lower compared with patients of normal weight. This review describes the physiologic abnormalities and clinical implications of obesity in cardiac surgery and summarizes recommendations for anesthesiologists to optimize perioperative care of the obese cardiac surgical patient.
PMID: 29358013
ISSN: 1532-8422
CID: 3061232

Anesthesia Matters: In Pursuit of the Interventions that Affect Outcomes in Transcatheter Aortic Valve Replacement [Editorial]

Neuburger, Peter J; Patel, Prakash A
PMID: 29506894
ISSN: 1532-8422
CID: 2979332

Conversion from Monitored Anesthesia Care to General Anesthesia for Transcatheter Aortic Valve Replacement

Kimmel, Joseph; Potosky, Ryan; Williams, Mathew R; Glading, Matthew; Neuburger, Peter J; Roberts, J Devin; Feider, Andrew
PMID: 29336966
ISSN: 1532-8422
CID: 2916172

Anesthetic Technique for TAVR: More Than Just "Tube" or "No Tube" [Editorial]

Neuburger, Peter J; Patel, Prakash A; Williams, Mathew R
PMID: 29153930
ISSN: 1532-8422
CID: 2907772

Postoperative Delirium in Transcatheter Aortic Valve Replacement: Future Steps to Make a Meaningful Attempt at Prevention [Editorial]

Patel, Prakash A; Neuburger, Peter J
PMID: 28967623
ISSN: 1532-8422
CID: 2720352